Important Safety Information Including Boxed Warning
WARNING: DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of BOTOX and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening, and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses and approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and spasticity and at lower doses.
Are There Any Other Important Points
Because Botox inhibits the action of bladder muscle, it is possible that the effect may be too much for your bladder, and that you may not be able to pass urine normally for as long as it takes the effect of Botox to wear off . This is rare, but if it occurred, you would need to perform intermittent self-catheterisation for this period of time. It is usual for you to be taught ISC before you have Botox to ensure that, in the rare event that you were affected in this way, you would be able pass a catheter yourself.
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Bladder Botox: Side Effects
Some people experience mild pelvic or abdominal discomfort after receiving Botox in the bladder. This has been described as a sensation like period cramps. This discomfort typically doesnt last more than a couple days. Other potential side effects from Botox injections in the bladder include:
- Urinary tract infection
- Difficulty urinating
- Inability to empty your bladder
These side effects are not common and are temporary. If you are experiencing any issues with urination after Botox injections in the bladder you should contact your doctor.
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Urinary Tract Infections In Patients With Overactive Bladder
BOTOX increases the incidence of UTI. Clinical trials for overactive bladder excluded patients with more than 2 UTIs in the past 6 months and those taking antibiotics chronically due to recurrent UTIs. Use of BOTOX for the treatment of overactive bladder in such patients and in patients with multiple recurrent UTIs during treatment should only be considered when the benefit is likely to outweigh the potential risk.
Serious Adverse Reactions With Unapproved Use
Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of BOTOX to the site of injection and/or adjacent structures. In several of the cases, patients had preexisting dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of BOTOX. The safety and effectiveness of BOTOX for unapproved uses have not been established.
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What To Expect After A Botox Injection In The Bladder
After your doctor finishes administering Botox in your bladder, they will monitor you in the office for about 30 minutes. You will be asked to empty your bladder before leaving the office and your doctor will check that no extra urine is retained when you use the restroom. Your doctor may prescribe 1-3 days of antibiotic pills to make sure you dont get an infection.
Botox Injections To Improve Bladder Control
As with other treatments, Botox has risks. Discuss the potential risks with your doctor before the procedure, such as:
- Blood in the urine right after the procedure. Small amounts are normal and are a temporary side effect.
- Urinary tract infections fewer than 15 percent of women who have Botox treatments need treatment for UTIs.
- Difficulty emptying the bladder women who experience this need to catheterize themselves or wear a catheter temporarily. This happens about 10 percent of the time and is not permanent.
- Allergic reactions to Botox, such as trouble breathing, vision problems, and generalized weakness.
Make sure you have all your questions answered ahead of time and know how to contact your surgeon with questions or problems after the procedure.
HOW THE PROCEDURE IS DONE
Botox injections are usually performed in a doctors office. You do not need general anesthesia or an overnight hospital stay. You can eat and drink normally on the day of the procedure. The actual procedure takes about 20 minutes. However, the entire visit may require one to two hours.
When you arrive, youll need to give a urine sample. This sample will be checked for signs of a UTI. If you have a UTI, the procedure will need to be rescheduled. If you have symptoms of a UTI at home, call the office right away.
AFTER THE PROCEDURE
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How Often Will I Get Botox Injections
How often you receive Botox injections may vary. Youll need to track the symptoms of your bladder condition so that your doctor can determine how often you need the injections.
The minimum period between injections is 12 weeks, but in some cases, people feel the effects of Botox for longer periods. This means that they may need injections less often.
If you have questions about how often youll need to get Botox injections for your condition, talk with your doctor.
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How Does Botox Work On The Bladder
Normally, the bladder muscle is in a relaxed state, and this is how urine accumulates in the bladder. When the amount of urine and pressure in the bladder rises above a certain value, the bladder muscle contracts and the patient needs to urinate. In people with overactive bladder disease, there are involuntary bladder muscle contractions even at very low levels of urine and the patient needs to urinate constantly, if he is late, he will miss his urine.
When Botox is injected into the bladder muscle, the continuous contraction of the bladder muscle is prevented, in other words, a temporary paralysis occurs in the bladder muscle.
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Botox Treatment For The Bladder
Botox is a powerful drug that acts to temporarily paralyze muscles when it is locally injected. Botox is known for its popular use in cosmetics, but it actually has far reaching medical applications. It is commonly used for diverse conditions like muscle spasticity, headaches, as well as the treatment of urinary incontinence.
Botox is a well-tolerated treatment and the application of this therapy ranges from simple conditions like overactive bladder to treatment of severely spastic bladders from neurologic disease. In many instances, Botox can be injected in a short procedure in our clinic. The therapy last for six to eight months and then is re-injected. There is no limitation to the duration of using this type of therapy.
What Can I Expect After Receiving Botox Injections For My Bladder Problem
After receiving a Botox injection, you may have improved bladder control for about 12 weeks. Some people may still have bladder control after 24 weeks. After this period, the effect of Botox wears off, and youll need more injections.
Your experience with Botox injections may vary. If you have questions about the results you can expect with this drug, talk with your doctor. And for more information, see the How effective is Botox? section below.
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Botox For Overactive Bladder
Approved new use
Botox isnt just for wrinkles anymore. In 2013, the U.S. Food and Drug Administration expanded the use of Botox to include the treatment of overactive bladder .
Overactive bladder isnt a disease, but rather a group of symptoms related to the function of your bladder. If you arent sure whether you have OAB, ask yourself these questions:
- Do I often experience an urgent need to urinate right away?
- Do I need to urinate at least eight times during the day, or more than twice at night?
- Do I frequently leak urine?
If you answer yes to at least two of these questions, then you may have OAB.
Are There Any Long
In general, you may have side effects within the first week of receiving Botox injections. Most of the time, these side effects are temporary, but sometimes, side effects can last for several months or longer.
But possible long-term side effects of Botox can include:
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Side Effects In Few Patients
The main side effect of the procedure, which occurs in about 5 to 8% of patients, is urinary retention, or problems emptying ones bladder.
Those patients may need temporary catheterization to guard against an increased risk of urinary tract infections, Dr. Vasavada says. And for that reason, some patients decide against the procedure.
We just cant predict whos likely to go into retention, he says. Its not a high likelihood, but not zero, either. We still have no direct ability to predict.
But most patients havent had that hesitancy, Dr. Vasavada says. Since its been approved for incontinence, its certainly generating more enthusiasm and interest, he says.
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How To Inject Botox
Botox injections are usually performed in a doctors office. Your doctor uses a thin needle to inject tiny amounts of botulinum toxin into your skin or muscles.The botulinum toxin is injected directly into the muscle, where it blocks nerve impulses to the muscle.The treatment takes only minutes and you can return to normal activities immediately. The effects of botulinum toxin wear off in three to four months, when you need another injection.
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How Do Bladder Botox Injections Work
Topics in this Post
Botox injections are not just for wrinkles on your face. They also can be used to help if you have ongoing bladder continence issues. Botox is one option to treat urge incontinence or overactive bladder in people who have not had success with other treatment options.
Urinary incontinence is common and can impair your social, physical or mental well-being. Approximately 17% of women and 3% to 11% of men suffer from urge incontinence at some point in their lives.
Urge incontinence is the unintentional loss of urine caused by your bladder contracting.
About Oab And Detrusor Overactivity
OAB and detrusor overactivity can both cause trouble with urination. With these conditions, you may have involuntary spasms in your bladder muscles, even when you dont actually need to urinate.
The exact cause of OAB isnt known. But some possible factors or causes may include:
- consuming caffeine, alcohol, or other bladder irritants
- taking medications that increase urine output
- other bladder problems, such as bladder stones
- not completely emptying the bladder
Detrusor overactivity can be linked with neurological conditions such as MS or a spinal cord injury. These neurological conditions affect how your brain communicates with the rest of your body. In some cases, they can cause bladder problems such as detrusor overactivity.
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What Are The Side Effects Of Botox
The lists below include some of the main side effects that have been reported in people using Botox. For information about other possible side effects of the drug, talk with your doctor or pharmacist.
Note: After the Food and Drug Administration approves a drug, it tracks and reviews side effects of the medication. If youd like to notify the FDA about a side effect youve had with Botox, visit MedWatch.
How Does Botox Work
Botox helps relieve the symptoms of bladder problems by promoting bladder control.
The detrusor muscle that lines the bladder plays an important role in bladder control. When the muscle relaxes, the bladder can fill with urine. When youre urinating, the muscle contracts to release urine.
If you have overactive bladder symptoms or detrusor overactivity, your bladder muscles spasm involuntarily . Botox is injected into the detrusor muscle to block the nerve signals to the muscle. This helps control the muscles contractions.
Below are answers to some commonly asked questions about Botoxs use in treating bladder conditions.
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What Are The Risks
There are risks with any operation but these are small. The main risks associated with botulinum toxin A bladder wall injection are:
- Blood stained urine. This is to be expected and should settle on its own within few days.
- The most frequent problem is initial difficulty in passing urine. This happens as a result of over relaxation of the bladder muscle. Patients may need to pass a catheter to help emptying their bladder themselves a practice called intermittent self catheterisation. It is therefore important that patients are aware of this possibility and able to perform clean self catheterisation themselves, in case they have to do this after the injection.
- Recurrence of overactive bladder symptoms. This may happen between 6 to18 months. It may necessitate a repeat injection, which is usually carried out every year or two years.
- Postoperative pain, which is usually mild and lasts for a day or two.
- Urinary tract infection, which may need antibiotics.
- Venous thrombosis and pulmonary embolism . These are extremely rare after such a minor operation.
- Failure to improve or cure overactive bladder symptoms. This is rare and may require alternative treatment.
- Allergic reactions can happen, but they are extremely rare. These take the form of general malaise and possible rash. You will need to contact your doctor or the hospital for medication.
Other Botox Aftercare Instructions
Donât get a facial or head massage for a full 24 hours after Botox. You should also avoid rubbing your face in the area that was treated.
Donât lie down for at least 3 hours after receiving Botox.
Dont go into any saunas, hot tubs, or tanning booths for at least 4 hours. This helps to prevent bruising, because heat can raise your blood pressure.
Otherwise, you can resume your regular activities right after getting Botox.
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Are There Any Side Effects Of Botox For Overactive Bladder
Side effects are unlikely, but as with any medication, they are a possibility.
The most common side effect is an increase in post-void residual, which means that the bladder is left with urine after going to the bathroom. Typically, this is not a problem. However, in about 6% of people during clinical trials, temporary catheterization was required. When this occurs, the person is instructed on how to self-catheterize and may be required to perform this procedure one to four times per day. In this small population, self-catheterization was required for two to six weeks.
The other side effects are blood in the urine and urinary tract infections. Urinary tract infections can occur with or without self-catherization.
Bronchitis And Upper Respiratory Tract Infections In Patients Treated For Spasticity
Bronchitis was reported more frequently as an adverse reaction in adult patients treated for upper limb spasticity with BOTOX compared to placebo . In adult patients with reduced lung function treated for upper limb spasticity, upper respiratory tract infections were also reported more frequently as adverse reactions in patients treated with BOTOX compared to placebo . In adult patients treated for lower limb spasticity, upper respiratory tract infections were reported more frequently as an adverse reaction in patients treated with BOTOX compared to placebo . In pediatric patients treated for upper limb spasticity, upper respiratory tract infections were reported more frequently as an adverse reaction in patients treated with BOTOX compared to placebo . In pediatric patients treated for lower limb spasticity, upper respiratory tract infection was not reported with an incidence greater than placebo.
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Pediatric Detrusor Overactivity Associated With A Neurologic Condition
The most frequently reported adverse reactions during the 12 weeks following BOTOX injection of 200 Units for pediatric detrusor overactivity associated with a neurologic condition include bacteriuria , UTI , leukocyturia , and hematuria .
The most common adverse reactions in patients who received BOTOX 6 Units/kg and less than a total dose of 200 Units were UTI, bacteriuria, and hematuria.
These patients were not adequately managed with at least one anticholinergic agent and were using CIC at baseline.
Who Is A Candidate For Botox Bladder Injections
This type of treatment is not for every patient. The procedure may be helpful for those who have bothersome OAB symptoms, such as urinary frequency , urgency and incontinence, and who have tried and failed with OAB medications. Botox bladder treatment may also be recommended for people who have medical conditions such as uncontrolled high blood pressure or glaucoma, or who have chronic constipation and therefore should not take OAB medications. The procedure is also approved for patients who have incontinence problems due to a neurologic condition, such as a spinal cord injury or multiple sclerosis .
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How Does Botox Help Overactive Bladder
About 20 years ago, researchers began to apply Botox to the bladder in quadriplegics who had spastic bladders. The treatment was so effective, that they next tried it out for people with OAB and the results were life changing.
Botox relaxes the bladder muscles, to reduce or eliminate the spastic condition that causes OAB. Overactive Bladder can be wet or dry, and Botox can help both conditions. With dry OAB, you frequently have the gotta go feeling and make too many trips to the bathroom. Those who suffer from wet OAB cannot make it to the bathroom in time, and wet their panties.
OAB occurs when the bladder is hyperactive, and the muscles in the bladder wall develop a spastic condition. Often, this occurs in neurological diseases such as multiple sclerosis or stroke, but for most women the cause is unknown. It is more common after menopause, so there is likely a hormonal component.